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Question 1. Which federal agency is responsible for approving new prescription drugs before they reach the market? A) DEA B) FDA C) CDC D) EPA Answer: B Explanation: The FDA oversees the approval of new drugs to ensure safety and efficacy before they are made available to the public. Question 2. What is the primary role of the Drug Enforcement Administration (DEA) in pharmacy law? A) Approving new drugs B) Monitoring food safety C) Regulating controlled substances D) Labeling over-the-counter medications Answer: C Explanation: The DEA regulates controlled substances to prevent misuse and diversion. Question 3. Which law first prohibited the sale of misbranded and adulterated drugs? A) Food, Drug, and Cosmetic Act B) Pure Food and Drug Act C) Poison Prevention Packaging Act D) Durham-Humphrey Amendment Answer: B Explanation: The Pure Food and Drug Act of 1906 addressed misbranding and adulteration of drugs.
Question 4. Which amendment created the distinction between prescription and over-the- counter drugs? A) Poison Prevention Packaging Act B) Durham-Humphrey Amendment C) Kefauver-Harris Amendment D) Food, Drug, and Cosmetic Act Answer: B Explanation: The Durham-Humphrey Amendment of 1951 established legend (prescription) and OTC drugs. Question 5. Who is responsible for licensing pharmacists and pharmacy technicians at the state level? A) DEA B) FDA C) Board of Pharmacy D) CDC Answer: C Explanation: State Boards of Pharmacy oversee licensure and regulation of pharmacy professionals. Question 6. What is the main requirement introduced by the Food, Drug, and Cosmetic Act of 1938? A) Drug labeling B) Child-resistant packaging C) Drug safety before marketing D) Drug efficacy
Question 10. Which federal form is used for a pharmacy to register with the DEA? A) DEA Form 106 B) DEA Form 224 C) DEA Form 41 D) DEA Form 222 Answer: B Explanation: DEA Form 224 is used for pharmacy registration with the DEA. Question 11. Which form must be completed to order Schedule II controlled substances? A) DEA Form 224 B) DEA Form 222 C) DEA Form 41 D) DEA Form 106 Answer: B Explanation: DEA Form 222 is required for ordering Schedule II drugs. Question 12. What does the Controlled Substances Act (CSA) primarily regulate? A) OTC drugs B) Controlled substances C) Food safety D) Cosmetic labeling Answer: B Explanation: CSA governs the handling and regulation of controlled substances.
Question 13. Which schedule of controlled substances has no accepted medical use in the United States? A) Schedule I B) Schedule II C) Schedule III D) Schedule IV Answer: A Explanation: Schedule I drugs have no accepted medical use and high abuse potential. Question 14. Which agency is responsible for recalling drugs due to safety concerns? A) DEA B) FDA C) EPA D) CDC Answer: B Explanation: The FDA issues recalls for drugs that pose safety risks. Question 15. How often must a pharmacy conduct a controlled substances inventory according to federal law? A) Annually B) Monthly C) Biennially D) Every five years Answer: C Explanation: Federal law requires an inventory every two years. Question 16. Which DEA form is used to report significant loss or theft of controlled substances?
B) Only patient name C) Only drug name D) Only prescriber phone number Answer: A Explanation: These are required elements for legal prescriptions. Question 20. What is the primary purpose of the Drug Supply Chain Security Act (DSCSA)? A) Labeling requirements B) Preventing drug diversion C) Tracking and tracing prescription drugs D) Efficacy testing Answer: C Explanation: DSCSA requires tracking and tracing to ensure drug supply chain integrity. Question 21. Which of the following is considered Protected Health Information (PHI) under HIPAA? A) Drug price B) Patient address C) Pharmacy license number D) Manufacturer’s name Answer: B Explanation: Patient addresses are part of PHI protected under HIPAA. Question 22. What is Tall Man Lettering used for? A) Highlighting drug recalls B) Preventing medication errors
C) Marketing drugs D) Identifying generic drugs Answer: B Explanation: Tall Man Lettering helps distinguish look-alike drug names to prevent errors. Question 23. Who is responsible for final verification of prescriptions in the pharmacy? A) Pharmacy technician B) Pharmacist C) Nurse D) Patient Answer: B Explanation: Only pharmacists can perform the final check and verification. Question 24. Which DEA form is used for drugs surrendered for disposal? A) DEA Form 41 B) DEA Form 106 C) DEA Form 222 D) DEA Form 224 Answer: A Explanation: DEA Form 41 documents disposal of controlled substances. Question 25. What is the main ethical duty of a pharmacy technician regarding patient confidentiality? A) Sharing patient information with family B) Reporting illegal activity C) Protecting patient privacy
Explanation: Recalled drugs must be removed from inventory to prevent patient harm. Question 29. What is the main function of the checksum formula for DEA numbers? A) Calculating drug prices B) Validating prescriber DEA numbers C) Tracking inventory D) Reporting theft Answer: B Explanation: The checksum formula ensures DEA numbers are valid for controlled substance prescriptions. Question 30. Which law established requirements for New Drug Applications (NDAs)? A) Pure Food and Drug Act B) Food, Drug, and Cosmetic Act C) Durham-Humphrey Amendment D) Poison Prevention Packaging Act Answer: B Explanation: The Food, Drug, and Cosmetic Act created NDA requirements. Question 31. What is the minimum age for purchasing pseudoephedrine-containing products according to federal law? A) No minimum B) 12 years C) 16 years D) 18 years Answer: D Explanation: Federal law restricts purchase to persons 18 and older.
Question 32. Who is responsible for maintaining competency in pharmacy practice? A) Only the pharmacist B) Pharmacy technician C) All pharmacy staff D) Only the manager Answer: C Explanation: Every pharmacy professional must maintain competency. Question 33. What type of information may a technician legally discuss with a patient’s family? A) Medication price B) PHI without patient consent C) Only with patient authorization D) Any information Answer: C Explanation: PHI can be discussed only if the patient consents. Question 34. Which agency sets standards for drug labeling and advertising? A) DEA B) FDA C) CDC D) EPA Answer: B Explanation: The FDA regulates drug labeling and advertising practices. Question 35. Which schedule of controlled substances has the lowest potential for abuse?
C) Incorrect pricing D) Drugs with similar names Answer: B Explanation: Adulterated drugs are contaminated or stored improperly, posing safety risks. Question 39. Which legislation focuses on preventing drug diversion and abuse? A) Pure Food and Drug Act B) Controlled Substances Act C) Poison Prevention Packaging Act D) Food, Drug, and Cosmetic Act Answer: B Explanation: The CSA is designed to prevent diversion and abuse. Question 40. Which of the following tasks may a pharmacy technician legally perform? A) Final prescription verification B) Patient counseling C) Data entry and medication preparation D) Prescribing medication Answer: C Explanation: Technicians can prepare and enter data but cannot verify or counsel. Question 41. What is the main requirement for pharmacy record retention under federal law? A) Retain for 6 months B) Retain for 1 year C) Retain for 2 years D) Retain indefinitely
Answer: C Explanation: Most federal laws require record retention for two years. Question 42. What information must be recorded for a biennial controlled substances inventory? A) Only drug names B) Drug name, strength, dosage form, quantity C) Patient addresses D) Prescriber DEA numbers Answer: B Explanation: Complete drug details are required for inventory records. Question 43. What is the consequence of dispensing a Schedule II prescription with missing prescriber signature? A) Dispense as written B) Call prescriber for verbal confirmation C) Do not dispense D) Technician may sign Answer: C Explanation: Schedule II prescriptions require the original prescriber signature. Question 44. Who enforces HIPAA regulations in the pharmacy setting? A) DEA B) FDA C) Office for Civil Rights D) State Board of Pharmacy Answer: C
Question 48. Which type of drug products require a New Drug Application (NDA) before marketing? A) All prescription drugs B) OTC drugs C) Dietary supplements D) Cosmetics Answer: A Explanation: Prescription drugs must have NDA approval before marketing. Question 49. What is the penalty for violating federal pharmacy law regarding controlled substances? A) Warning only B) Fines and possible imprisonment C) Loss of technician registration D) No penalty Answer: B Explanation: Violations can result in severe fines and imprisonment. Question 50. Who is responsible for reporting illegal or unethical behavior in the pharmacy? A) Only the pharmacist B) Technician and pharmacist C) Only the manager D) No one Answer: B Explanation: All pharmacy staff are ethically obligated to report illegal behavior.
Question 51. What is the main purpose of the Durham-Humphrey Amendment? A) Establish child-resistant packaging B) Differentiate legend and OTC drugs C) Require drug efficacy D) Monitor controlled substances Answer: B Explanation: The amendment established prescription (legend) and OTC drug categories. Question 52. Which of the following is NOT considered a controlled substance? A) Morphine B) Ibuprofen C) Alprazolam D) Hydrocodone Answer: B Explanation: Ibuprofen is not a controlled substance. Question 53. What is the proper procedure for handling a forged prescription? A) Fill immediately B) Report to DEA and refuse to fill C) Alter prescription D) Ignore Answer: B Explanation: Forged prescriptions should be refused and reported. Question 54. Who can legally prescribe controlled substances? A) Any pharmacy staff
C) Sell at discount D) Ignore Answer: B Explanation: Class II recalls are for drugs causing temporary or reversible health issues. Question 58. Which federal law requires the reporting of significant controlled substance theft or loss? A) Food, Drug, and Cosmetic Act B) Controlled Substances Act C) HIPAA D) Durham-Humphrey Amendment Answer: B Explanation: The CSA mandates reporting of significant loss or theft. Question 59. Which of the following is legally required on a controlled substance prescription? A) Patient name, drug name, dosage, prescriber signature, DEA number B) Only patient name C) Only DEA number D) Only drug price Answer: A Explanation: These elements are required for controlled substance prescriptions. Question 60. What does CSOS stand for in pharmacy law? A) Controlled Substances Ordering System B) Clinical Safety Oversight System C) Cosmetic Safety Online System
D) Controlled Security Online Storage Answer: A Explanation: CSOS is the electronic system for ordering controlled substances. Question 61. What is the main function of the Poison Prevention Packaging Act? A) Drug approval B) Child-resistant packaging C) Drug labeling D) Prescription verification Answer: B Explanation: The Act requires child-resistant packaging for most drugs. Question 62. What is considered a breach of patient confidentiality? A) Discussing PHI without authorization B) Reporting theft C) Ordering drugs D) Refilling prescriptions Answer: A Explanation: Discussing PHI without consent is a breach of confidentiality. Question 63. Which schedule includes drugs with accepted medical use and high abuse potential? A) Schedule I B) Schedule II C) Schedule III D) Schedule IV
